Initial reporter phone#: (b)(6).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot#: 0071631, medical device expiration date: 28-feb-2025, device manufacture date: 11-mar-2020, medical device lot#: 0083097, medical device expiration date: 28-feb-2025, device manufacture date: 23-mar-2020, medical device lot#: 0127985, medical device expiration date: 30-apr-2025, device manufacture date: 06-may-2020, medical device lot#: 0090399, medical device expiration date: 31-mar-2025, device manufacture date: 30-mar-2020.
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-feb-2023.H6: investigation summary nine samples and two photos were provided to our quality team for investigation.A visual inspection was performed.Two samples were observed to have minor cosmetic scuffing inside and outside of the print area on the mid-point of the barrel.One sample was observed to have a snapped plunger thumb-rest.Six samples were observed to have one vertical crack extending up the barrel.Potential root cause for the cracked barrel and broken thumb-rest defects are associated with the assembly process.It could be possible that an inadvertent jam or improper transfer between assembly dials led to the condition observed.These defects are occurring at an expected rate so no corrective actions will be made at this time.A device history record review was completed for provided lot numbers 0071631, 0083097, 0127985 and 0090399.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.H3 other text : see h10.
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